GlaxoSmithKline announced that Shingrix, its shingles vaccine candidate, met its primary endpoint in a phase 3 trial of adults aged 70 years and older.
The vaccine demonstrated 90% (95% CI, 84-94) efficacy against shingles compared with placebo, according to a press release. The result of the ZOE-70 trial was comparable with ZOE-50, a phase 3 study in adults aged 50 and older presented earlier in 2015, the release reported.
The shingles vaccine candidate is a non-live vaccine that combines gE, a protein found on the virus that causes shingles, with an adjuvant system that enhances the immunologic response to gE, according to the release.
More than 14,800 adults aged 70 years and older participated in the ZOE-70 multicenter, placebo-controlled trial with two doses given intramuscularly 2 months apart, according to the release. More than 16,000 adults aged 50 years and older participated in the ZOE-50 trial, which involved the same dosing schedule.
Subsequent chronic neuropathic pain, also known as postherpetic neuralgia (PHN), the most common severe complication of shingles, was effectively prevented by the vaccine, according to pooled analysis of the trials. The vaccine was 89% efficacious (95% CI, 69-97) in preventing PHN in patients aged 70 years and older and 91% efficacious (95% CI, 76-98) in preventing PHN in patients aged 50 years and older, according to the release.
“Together, these remarkable results underscore the potential of a candidate vaccine to prevent both shingles and PHN in older adults,” Alain Brecx, MD, vaccine development leader at GlaxoSmithKline, stated in the release. “About 90% of people 50 years and over are at risk of developing shingles, a painful disease that negatively impacts people’s health and quality of life.”
More than 16,000 people have received the vaccine in phase 1, 2 and 3 trials, according to the release. Adverse events experienced in 7 days after vaccination included pain, redness and swelling at the injection site and muscle pain, fatigue and headache.
Based on the phase 3 data, GlaxoSmithKline intends to submit a regulatory application for Shingrix in preventing shingles in people aged 50 years and older in North American, Japan and the European Union in the second half of 2016, according to the release.